Cresemba Approval Supported by FDA Advisory Committee
Astellas announced that the Anti-infective Drugs Advisory Committee of the Food and Drug Administration (FDA) has recommended the approval of Cresemba (isavuconazonium) for the treatment of invasive aspergillosis and mucormycosis (also known as zygomycosis).
Cresemba is an investigational once-daily intravenous and oral broad-spectrum antifungal. The Committee's recommendation is supported by data from two Phase 3 clinical trials: SECURE and VITAL. SECURE is a randomized, double-blind, active-control study of adults with invasive aspergillosis. VITAL is an open-label non-comparative study of adults with invasive aspergillosis and renal impairment or adults with invasive fungal disease caused by other rare fungi.
The New Drug Application (NDA) review is expected to be complete by March 8, 2015.
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